QA Specialist CSV

Fidel Consulting KK · Hanzomon (Hybrid) , Tokyo (Hybrid) , Japan

Location
Hanzomon (Hybrid)
Job Type
Full-time
Posted
July 02, 2026

Job Description


 Appealing Points:


Lead Quality & Compliance in Global Pharma IT – Ensure GxP compliance, computer system validation, and data integrity across complex global IT systems and regulated processes.
Drive Regulatory Excellence – Lead validation oversight, audit readiness, and quality governance while ensuring compliance with 21 CFR Part 11 and global pharmaceutical standards.
Influence Enterprise-Wide Quality Initiatives – Partner with cross-functional global teams to improve validation processes, quality systems, and regulatory compliance through expert QA leadership.


Annual salary: 7 Million Yen and above

Job Responsibilities:


GxP SLC Documentation Review & Compliance Oversight


Utilize risk-based approaches to validation oversight and quality decision-making across global IT and regulated business processes.
Provide QA oversight of change control activities associated ...

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